San Antonio, Dec. 10, 2004 Today, results of a study presented at the 27th Annual San Antonio Breast Cancer Symposium show that an ELLENCE (epirubicin hydrochloride injection) based chemotherapy regimen delivers survival benefits when used alone or in combination with docetaxel. The results of the study, which compares a sequential regimen of FEC 100 (fluorouracil 500 mg/m2, epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2) followed by docetaxel 100mg/m2 to FEC 100 alone, builds upon an existing body of survival and safety evidence for ELLENCE including previously reported 10-year disease free and overall survival data. In both arms of the study, patients achieved disease-free and overall survival outcomes which set a new survival standard for the drug.
"These results reaffirm that ELLENCE is an integral component of treatment of patients with node positive breast cancer," said William Gradishar, MD, Associate Professor of Medicine in the Division of Hematology and Medical Oncology at Northwestern University Medical School. "Patients stand to benefit from the significant outcome advantages delivered from these two ELLENCE-based regimens."
The data from this large phase III randomized, multi-center clinical trial that evaluated nearly 2,000 patients were presented by Dr. Henri Roche on behalf of a consortium of French and Belgian oncologists and showed that patients receiving sequential treatment achieved a disease free survival rate of 78.3% in the sequential arm and 73.2% in the FEC 100 only arm. In addition, patients treated with the sequential regimen achieved overall survival of 90.7% and those treated with FEC alone achieved overall survival of 86.7%.
This independent study, coordinated by the Fdration Nationale des Centres de Luttes Contre le Cancer (FNCLCC), was partially funded by Pharmacia Corporation, now part of Pfizer Inc. Pfizer is the manufacturer of ELLENCE.
Study Results and Design
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